She was asked whether there was anything new or different in the Wurst study. "Well, the only thing that is different in ... the published version versus unpublished version," she said, "is that they did not publish any subgroupings of cardiac abnormalities, birth defects in the published version."
They only "analyzed and published the summary odds ratio for all cardiac birth defects combined," she noted.
"And that summary odds ratio was very similar to the first one," she said. "It's 1.46. That is a 46-percent increased risk for all cardiac defects combined."
During cross-examination, Glaxo attorney, Todd Davis, told Kramer, "despite every single one of those studies looking at that those different patient populations over different time periods, there is not a single case in any of the studies that you talked about ... that identifies a patient who was exposed to Paroxetine or Paxil who had an IAA ..."
He noted that Lyam "was diagnosed with an interrupted aortic arch Type A," and asked Kramer: "Can you -- can you point to the jury in your report where you mention anything about interrupted aortic arch of any kind?"
"I probably didn't because there is no specific study that analyzed that specific defect as a stand alone category," she replied.
Kramer pointed out that "the epidemiological studies that have been conducted never individually analyzed the rates of the risk of interrupted aortic arch Type A associated with first trimester Paxil exposure."
Because it is so very rare, she said, it would be impossible to do given the required sample size of "something over a million" subjects in order to conduct such a study.
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